Alkermes’ Corporate Presentation to be Webcast at the Cowen and Company 39th Annual Health Care Conference

On March 5, 2019 Alkermes plc (Nasdaq: ALKS) reported that its corporate presentation will be webcast live at the Cowen and Company 39th Annual Health Care Conference on Tuesday, Mar. 12, 2019 at 8:40 a.m. ET (12:40 p.m. GMT) from Boston (Press release, Alkermes, MAR 5, 2019, View Source;p=RssLanding&cat=news&id=2390204 [SID1234534020]). The presentation may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction, multiple sclerosis and oncology. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.

Xenetic Biosciences Announces Pricing of $3.1 Million Registered Direct Offering

On March 5, 2019 Xenetic Biosciences, Inc. (NASDAQ: XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on the acquisition, research and development of novel oncology therapeutics, including next-generation cellular immunotherapies for difficult to treat cancers, including B-cell Lymphomas, as well as improved biologic drugs, reported it has entered into a securities purchase agreement with a single accredited institutional investor to purchase approximately $3.1 million of the Company’s common stock (the "Common Stock") (or pre-funded warrants to purchase Common Stock in lieu thereof) in a registered direct offering (the "Offering") and warrants to purchase shares of Common Stock in a concurrent private placement (Press release, Xenetic Biosciences, MAR 5, 2019, View Source [SID1234534012]). The combined purchase price for one share of Common Stock (or pre-funded warrants to purchase Common Stock in lieu thereof) and each warrant will be $2.00.

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Under the terms of the securities purchase agreement, Xenetic has agreed to sell 1,549,000 shares of Common Stock (or pre-funded warrants to purchase Common Stock in lieu thereof). In a private placement, which will be consummated concurrently to the Offering, Xenetic also agreed to issue warrants to purchase up to an aggregate of 1,549,000 shares of Common Stock. The warrants will be exercisable six months following the date of issuance, will expire on the seventh anniversary of the initial exercise date and have an exercise price of $2.25 per share of Common Stock.

The gross proceeds to Xenetic from the registered direct offering are expected to be approximately $3.1 million before deducting placement agent fees and other offering expenses. The offering is expected to close on or about March 7, 2019, subject to the satisfaction of customary closing conditions.

Maxim Group LLC is acting as the exclusive placement agent for the Offering.

The shares of Common Stock and pre-funded warrants are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-227572), which was declared effective by the United States Securities and Exchange Commission ("SEC") on October 12, 2018. The warrants are being issued in a private placement concurrent to the Offering and Common Stock issuable upon the exercise of such warrants were offered under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and have not been registered under the Act or applicable state securities laws. Accordingly, the warrants and underlying shares of Common Stock may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from registration requirements of the Act and such applicable state securities laws.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. A prospectus supplement relating to the shares of Common Stock and pre-funded warrants will be filed by Xenetic Biosciences, Inc. with the SEC. When available, copies of the prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from Maxim Group LLC, 405 Lexington Avenue, New York, NY 10174, Attention: Syndicate Department, or via email at [email protected] or telephone at (212) 895-3745.

Aura Biosciences to Present at Upcoming Investor Conferences

On March 5, 2019 Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, reported that management will present a company overview at the following investor conferences (Press release, Aura Biosciences, MAR 5, 2019, View Source [SID1234534010]):

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Cowen and Company 39th Annual Health Care Conference on Tuesday, March 12, 2019, at 10:00 a.m. Eastern Time in Boston, MA

Oppenheimer’s 29th Annual Healthcare Conference on Tuesday, March 19, 2019, at 9:10 a.m. Eastern Time in New York, NY

Neurocrine Biosciences to Present at Upcoming Healthcare Conferences

On March 5, 2019 Neurocrine Biosciences, Inc. (NASDAQ: NBIX) reported that Kevin Gorman, Chief Executive Officer, and Matt Abernethy, Chief Financial Officer, of Neurocrine Biosciences will present at the following investor conferences (Press release, Neurocrine Biosciences, MAR 5, 2019, View Source;p=RssLanding&cat=news&id=2390205 [SID1234534009]):

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Cowen 39th Annual Health Care Conference at 10:00 a.m. ET on Tuesday, March 12, 2019, in Boston.
Barclays Global Healthcare Conference at 11:15 a.m. ET on Wednesday, March 13, 2019, in Miami.
(PRNewsfoto/Neurocrine Biosciences, Inc.)
The live presentations will be webcast and may be accessed on the Company’s website under Investors at www.neurocrine.com. A replay of the presentations will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

TESARO Announces Data Presentations at the 2019 SGO Annual Meeting on Women’s Cancer

On March 5, 2019 TESARO, an oncology-focused business within GSK, reported that data for dostarlimab (anti-PD-1 antibody, formerly TSR-042) and Zejula (niraparib) will be presented at the 2019 Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer being held March 16-19 in Honolulu, Hawaii (Press release, TESARO, MAR 5, 2019, View Source [SID1234534006]).

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"At this year’s SGO meeting, data will be presented from the GARNET trial of dostarlimab in recurrent endometrial cancer patients, including patients with recurrent MSS endometrial cancer, for which limited treatment options exist today," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "We are on track to submit a BLA for dostarlimab by the end of the year. Data will also be presented from several studies of Zejula in patients with ovarian cancer, including safety data from the fully enrolled Phase 3 PRIMA study of Zejula as a first-line maintenance therapy for ovarian cancer regardless of BRCA status."

Please plan to visit TESARO at Booth #207 for information on the expanded development program for Zejula, dostarlimab and our broader pipeline.

Oral Presentations Information (all times local):

Dostarlimab (TSR-042)

Tuesday, March 19, 2019, 7:45 AM to 9:00 AM
Preliminary safety, efficacy, and pharmacokinetic/pharmacodynamic characterization from GARNET, a phase I/II clinical trial of the anti–PD-1 monoclonal antibody, TSR-042, in patients with recurrent or advanced MSI-H and MSS endometrial cancer (EC)
Oral in the Scientific Plenary VI, Abstract: 33, Location: Kamehameha 3

Zejula (niraparib)

Saturday, March 16, 2019, 6:45 AM to 7:45 AM
Time without symptoms or toxicity in patients with recurrent ovarian cancer receiving niraparib maintenance treatment versus placebo: A TWIST analysis of the ENGOT-OV16/NOVA trial
Oral in the Scientific Plenary I, Abstract: 1, Location: Kamehameha 3

Saturday, March 16, 2019, 6:45 AM to 7:45 AM
Baseline platelet count and body weight as predictors of early dose modification in the QUADRA trial of niraparib monotherapy for the treatment of heavily pretreated (≥4th line), advanced, recurrent high-grade serous ovarian cancer (OC)
Oral in the Scientific Plenary I, Abstract: 2, Location: Kamehameha 3

Saturday, March 16, 2019, 6:45 AM to 7:45 AM
A prospective evaluation of tolerability of niraparib dosing based upon baseline body weight and platelet count: Blinded pooled interim safety data from the ENGOT-OV26/PRIMA study
Oral in the Scientific Plenary I, Abstract: 3, Location: Kamehameha 3

Niraparib is marketed in the United States and Europe under trade name Zejula.

About Zejula (niraparib)
Zejula (niraparib) is a poly (ADP-ribose) polymerase (PARP) 1/2 inhibitor indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. In preclinical studies, Zejula concentrates in the tumour relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumour effect. Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including some fatal cases, was reported in patients treated with Zejula. Discontinue Zejula if MDS/AML is confirmed. Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia), as well as cardiovascular effects (hypertension and hypertensive crisis) have been reported in patients treated with Zejula. Monitor complete blood counts to detect hematologic adverse reactions, as well as to detect cardiovascular disorders, during treatment. Zejula can cause fetal harm and females of reproductive potential should use effective contraception. Please see full prescribing information, including additional important safety information, available at www.zejula.com.

About GARNET
The ongoing Phase I/II GARNET trial is evaluating dostarlimab as monotherapy in patients with advanced solid tumors. GARNET included a weight-based dose escalation study (Part 1) and a fixed-dose safety study (Part 2A), both of which have been completed. Results of these studies were used to determine the recommended Phase 2 dose (RP2D; 500 mg Q3W for the first 4 cycles then 1000 mg Q6W). Part 2B of the study includes four large expansion cohorts: MSI-H endometrial cancer, MSI-H non-endometrial cancer, MSS endometrial cancer, and non-small cell lung cancer (NSCLC).

About dostarlimab
Dostarlimab (TSR-042) is an investigational humanized anti-programmed death (PD)-1 monoclonal antibody that binds with high affinity to the PD-1 receptor and effectively blocks its interaction with the ligands PD-L1 and PD-L2. Dostarlimab is the only anti-PD-1 therapy administered as monotherapy every 3 weeks for 4 doses then every 6 weeks thereafter. Dostarlimab was developed as part of the collaboration between TESARO and AnaptysBio, Inc. This collaboration was initiated in March of 2014, and is focused on the development of monospecific antibody drugs targeting PD-1, TIM-3 (TSR-022), and LAG-3 (TSR-033), in addition to a bi-specific antibody drug candidate targeting PD-1/LAG-3 (TSR-075).